Bendit Technologies has secured 510(k) clearance from the U.S. Food and Drug Administration for its Bendit17 steerable microcatheter, a device the company describes as the smallest steerable microcatheter available for use in neurovascular and peripheral endovascular interventions. With U.S. commercialization slated to begin in January 2026, the Israel-based medical device manufacturer is also pursuing regulatory […]
Neurizon Therapeutics Limited has received clearance from the United States Food and Drug Administration for its investigational therapy NUZ-001 to be included in the HEALEY ALS Platform Trial, a globally recognized adaptive trial framework for amyotrophic lateral sclerosis. The decision formally designates NUZ-001 as Regimen I in the platform, allowing clinical site activation and study […]
Medtronic’s Hugo robot gets FDA clearance for urology. Explore how it could reshape U.S. robotic surgery and challenge incumbent systems like da Vinci.
